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  5. ByPro Nutrition LLC - 646308 - 04/04/2023
  1. Warning Letters

WARNING LETTER

ByPro Nutrition LLC MARCS-CMS 646308 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Robert L Bynum
Recipient Title
Owner
ByPro Nutrition LLC

1906 Potomac Dr.
Columbia, MO 65203-5843
United States

Issuing Office:
Division of Human and Animal Food Operations West II

United States

WARNING LETTER

April 4, 2023

RE: CMS CASE # 646308

Dear Dr. Robert L Bynum:

This is to advise you that the Food and Drug Administration (FDA) reviewed your product label for Dodecin following an inspection of your facility at 1906 Potomac Dr., Columbia, MO 65203 between August 10, 2022 and August 17, 2022. In addition, FDA reviewed your website at the Internet address www.bypronutrition.com in October and November 2022, and March 2023 and has determined that you take orders there for the product Dodecin. The claims on your product label and website establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs/Misbranded Drugs

Examples of some of the claims on your product label and website that provide evidence that your Dodecin product is intended for use as a drug include:

On the product label:

  • “DODECIN: The ingredients in Dodecin are formulated to address multiple pain and inflammation pathways.”

On your website www.bypronutrition.com:

On your Order Now page, for the single product Dodecin:

  • “Dodecin - Pain and Inflammation Relief”
  • “When you're in pain, there's only one thing you care about - RELIEF. Thousands of people have experienced the life-changing benefits of Dodecin™.”
  • “Dodecin™ is a nutraceutical supplement developed by a physician who, like you, is a chronic pain sufferer.”
  • “Dodecin™ is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.”

On your Dodecin’s Ingredients page:

  • “Curcumin inhibits inflammation in and around your joints, muscles, and other tissues, thus decreasing associated aches and pains.”
  • “MSM . . . [R]eleiving [sic] many of the symptoms associated with arthritis, osteoarthritis, and rheumatoid arthritis.”
  • “ALA is a reputable therapy for preventing nerve pain. It also detoxifies your body; fighting…toxic metals, such as Mercury.”
  • “Medical research studies show that Silymarin, found in Milk-Thistle, decreases inflammation of tissue and relieves associated pain.”
  • “Trypsin…Combined with bromelain, it helps treat conditions such as osteoarthritis.”
  • “CMO also regulates inflammation -reducing pain.”
  • “Bromelain is a powerful anti-inflammitory nutrient. In recent years, numerous clinical studies have shown that bromelain is potentially more effective than many prescription drugs in relieving pain caused by inflammation.”
  • “Boswellia Seratta is used clinically to treat degenerative & inflammatory joint disorders. It reduces the white blood cell count in joint fluid, and inhibts leukocyte elastase, which is released in rheumatoid arthritis.”
  • “Glucosamine combined with MSM can also be effective against osteoarthritis, and the pain caused by inflamed joints.”

On your Dodecin Benefits page:

  • “Dodecin’s benefits include:…Back and joint chronic pain relief…Reduction in Nerve (neuropathy) Pain”
  • “Dodecin can also Provide:…Reduction in chronic Inflammatory Skin Conditions…Reduction in Fibromyalgia & other chronic pain syndromes”
  • “Chronic inflammation and pain need to have a loading dose to suppress the over load occurring in your body. Just like steroid dosing for acute inflammation your doctor typically will give a short burst to quickly suppress the inflammation.”

On your Dodecin FAQs page:

  • “What is Dodecin?”… “Dodecin™ is a physician formulated nutraceutical (dietary supplement) designed to address pain and inflammation pathways.”
  • “What are the ingredients in Dodecin?”… “Dodecin™ is formulated from 12 ingredients that support the anti-inflammatory biochemical pathways:”
  • “Does DodecinTM work for everybody?”… “Dodecin™, typical onset of pain control is 3 to 7 days.”
  • “How quickly should I expect to notice results?”… “until you find the amount needed for inflammation or pain control.”

On the Youtube video attached to your homepage, you make the following statements in the video:

  • “[F]ormulated for the management of chronic pain syndromes”
  • “Dodecin has 12 different ingredients to address different pathways of pain”
  • “[T]his is something that you can do that actually addresses the inflammation in pain”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Dodecin for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your Testimonials page:

  • “My pharmacist recommended this product to me after I complained about pain all the time all over from osteoarthritis. She said try this it is all natural and we have been having people report fantastic results! So I bought a bottle of Dodecin and started taking according to directions. Wow within two days I was notice I got a difference in pain throughout my body.”
  • "My wife is going through chemo and her arthritis has been nearly killing her. Dodecin worked for her -then I tried it and we both love it. It worked within a matter of days!"
  • “I prefer Dodecin over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.”
  • “I soon grew tired of fighting the common cold and decided the joint pain and swelling from the Lupus would be more tolerable. Then I discovered Dodecin. After taking Dodecin for two days I started feeling much better. I have been taking Dodecin for 8 months and it has kept my Lupus symptoms in check. I no longer use any other medication to treat my Lupus except for Dodecin.”

Your Dodecin product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Dodecin product is intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Dodecin product fails to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Attention: Andrew A. Hoopes, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have questions regarding this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or via e-mail at: andrew.hoopes@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food Operations,
West Division II

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